This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study investigates the potential complementary effects of methanolic rosemary extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.
This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study evaluates changes in metabolic parameters, including fasting serum glucose and glycated hemoglobin (HbA1c); oxidative stress and antioxidant biomarkers, including malondialdehyde (MDA), superoxide dismutase (SOD), and reduced glutathione (GSH); and inflammatory biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP). Cytogenetic outcomes are assessed in exfoliated buccal epithelial cells using the buccal micronucleus cytome (BMCyt) assay. These outcomes include micronuclei and other nuclear abnormalities associated with genomic damage and cytotoxicity. Cytogenetic assessments are performed at baseline (Day 0), Month 1, and Month 3. Selected inflammatory and cardiovascular biomarkers are assessed at baseline, Month 3, and Month 6. These include IL-6, TNF-α, CRP, and Troponin T, allowing evaluation of inflammatory and cardiovascular-related changes during the extended follow-up period. Overall, the study aims to investigate the potential complementary effects of methanolic Rosmarinus officinalis extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Inactive substance with no therapeutic effect.
Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks
ISSSTE (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado)
Zacatecas City, Zacatecas, Mexico
Change in levels of Glutathione (GSH)
Evaluation of reduced glutathione (GSH) concentration as an indicator of antioxidant status (µmol/L).
Time frame: Baseline (Day 0) and Month 3.
Change in levels of glycated hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) (%).
Time frame: Baseline (Day 0) and Month 3.
Change in serum levels of Malondialdehyde (MDA)
Measurement of serum malondialdehyde concentration as a marker of lipid peroxidation and oxidative stress. Change in serum malondialdehyde (MDA) levels (nmol/mL).
Time frame: Baseline (Day 0), Month 1, Month 2, Month 3.
Change in antioxidant enzyme activity of Superoxide Dismutase (SOD)
Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL).
Time frame: Baseline (Day 0) and Month 3.
Change in the frequency of micronuclei and nuclear buds in buccal epithelial cells
Change in the frequency of micronucleated cells and cells with nuclear buds in exfoliated buccal epithelial cells assessed using the buccal micronucleus cytome (BMCyt) assay. Results are expressed as the number of cells presenting micronuclei or nuclear buds per 2,000 cells evaluated.
Time frame: Baseline (Day 0), Month 1 and Month 3.
Change in the frequency of nuclear abnormalities in buccal epithelial cells
Change in the frequency of nuclear abnormalities assessed using the BMCyt assay, including binucleated cells, condensed chromatin, karyorrhexis, pyknosis, and karyolysis. Results are expressed as the number of cells presenting each nuclear abnormality per 2,000 evaluated cells.
Time frame: Baseline (Day 0), Month 1 and Month 3.
Change in fasting plasma glucose (FPG)
Change in fasting plasma glucose (mg/dL).
Time frame: Baseline (Day 0), Month 3 and Month 6.
Change in serum levels of Interleukin-6
Quantification of IL-6 levels using immunoassay techniques. Change in serum interleukin-6 (IL-6) levels (pg/mL).
Time frame: Baseline (Day 0), Month 3, and Month 6.
Change in serum levels of Tumor Necrosis Factor Alpha
Evaluation of TNF-α as a marker of systemic inflammation. Change in serum tumor necrosis factor-alpha (TNF-α) levels (pg/mL).
Time frame: Baseline (Day 0), Month 3, and Month 6.
Change in serum Troponin T levels
Change in serum Troponin T concentration as a biomarker of cardiovascular involvement. Troponin T will be measured using an enzyme immunoassay according to the manufacturer's instructions (pg/mL).
Time frame: Baseline (Day 0), Month 3, and Month 6.
Change in levels of C-Reactive Protein (CRP)
Evaluation of CRP as a marker of systemic inflammation. Change in serum CRP levels (pg/mL).
Time frame: Baseline (Day 0), Month 3, and Month 6.
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